On 9 December 2021, the Medical Device Coordination Group published a question and answers document concerning obligations applicable to importers and distributors under Articles 13 and 14 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
On 25 November 2021, the European Commission adopted Implementing Regulation (EU) 2021/2071 subjecting vaccines against COVID-19 and active substances used for the manufacture of same to export surveillance for a period of 24 months starting from 1 January. This Regulation will replace the existing regulatory framework requiring vaccine exports to be subject to an authorization by Member States.
Pending the full functionality of the European Database on Medical Devices, the European Commission made available two new modules, to be used on a voluntary basis, for the registration of medical devices by economic operators and for the registration of certificates of conformity by notified bodies.
As every year since the creation of the reference price system back in 2014, the Spanish Ministry of Health published the new Reference Price Order Order SND/1308/2021 (“Order”) on 29 November 2021. The reference price system consists of the annual revision of the maximum price at which medicinal products included in the National Health System portfolio are financed. Our team already analyzed the draft Order published on 14 July 2021, and the final text barely differs from the draft.
On 29 November 2021, Legislative Decree No. 179/2021 was published in the Official Journal, introducing the applicable sanctions for violations of Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products. The new sanctions entered into force on 14 December 2021.
The Rating (Coronavirus) and Directors Disqualification (Dissolved Companies) Act (“Act”) received royal assent on 15 December 2021. The Act extends the scope of powers available to the Insolvency Service to address the issue of directors dissolving companies to avoid paying their liabilities.
Laura Fisher, Of Counsel in London’s Corporate Group, takes a look at the key climate-related reporting requirements in the UK, as well as the key developments you should be aware of in this ever-changing landscape.
The Baker McKenzie London Employment team is delighted to share with you episode one of our new virtual miniseries, “Employment Rights: is 2022 the year of enforcement?”, where we will be taking an in-depth look into the areas we believe there will be significant developments to the enforcement of UK employment rights in 2022 and beyond.
Today, more than 28 million people in the EU work through digital platforms in a wide variety of sectors. With the aim of improving the working conditions of these platform workers, the Commission published a proposal for a Directive on 9 December 2021. According to the Commission, the proposed Directive should ensure greater protection of platform workers. If the Directive is adopted, European member states will have two years to adapt their national legislation accordingly.
EU Member States must implement the European Whistleblowing Directive (EU WBD) by 17 December 2021. However, only Denmark, Sweden and Portugal have passed their implementing legislation.